The present invention concerns a spike connector of the type utilized to connect a tubing set to a medical solution container or bag. More particularly, the present invention is directed to a unitary molded one-piece frangible spike connector.
Many medical solution containers typically have an outlet port extending therefrom, with the port having a transverse diaphragm adapted for breakage by a spike from a tubing set. When the spike is inserted into the port, the transverse diaphragm is broken and the medical liquid can flow from the medical container through the spike and the tubing set to the patient.
In certain applications a sterile medical solution is utilized and it is important that the sterility of the system be maintained. For example, in peritoneal dialysis a dialysate solution is introduced into a patient's peritoneal cavity and is thereafter drained from the peritoneal cavity to the original solution container or elsewhere.
The medical procedure known as continuous ambulatory peritoneal dialysis (CAPD), described in U.S. Pat. No. 4,239,041, has rapidly grown in clinical acceptance as the technique of choice for maintaining many patients who have lost kidney function. Peritoneal dialysis solution is inserted in the peritoneal cavity, whereby diffusion exchange takes place between the solution and the bloodstream across the peritoneal membrane, to remove by diffusion the waste products which are normally excreted through the kidneys, typically solutes such as sodium and chlorine ions and the other materials normally excreted by the body such as urea, creatinine and water.
In the CAPD technique, the patient is surgically equipped with an implanted catheter which communicates between the peritoneal cavity and the exterior. Peritoneal dialysis solution is passed into the peritoneal cavity where dialysis of urea and the like takes place between the solution and the blood passing through blood vessels in the peritoneum, which is the lining of the peritoneal cavity. Thereafter, this peritoneal dialysis solution is removed from the peritoneal cavity, carrying with it diffused breakdown products from the blood. Fresh dialysis solution is then passed into the peritoneal cavity, and this process of filling and emptying is repeated several times.
In the CAPD technique, as with all techniques of peritoneal dialysis, peritonitis is one of the most significant risks. Peritonitis can result if connections are made between the peritoneal catheter and a set communicating with a source of dialysis solution in a manner which permits even a very small number of microorganisms to enter the catheter and to be flushed into the peritoneal cavity.
Examples of other areas where sterile connections are desirably made, and in which the present invention may be utilized can include the processing of blood and its fractions, the mixing of sterile solutions, connecting Foley catheters with urinary drainage bags, and hemodialysis or blood oxygenation procedures especially with patients who have diminished immunological capability. Also, the invention may be used to provide sterile conditions to a protective enclosure surrounding an indwelling catheter or the like.
Many types of spike connectors and connector assemblies have been proposed for use with such solution containers. Various types of sterilization also have been suggested, alone or in conjunction with various spike connectors. Typically, the spike connector assemblies are multipiece units which have a molded body with a metal needle inserted therein and a cover member inserted thereover. Molded spike connectors also have been utilized with sterilization techniques and/or with separate covers for the spike connector assemblies. Each of these prior assemblies require numerous pieces and multiple assemby steps.
It would be desirable to have a unitary one-piece spike connector, which also includes an integral cover for the spike connector and can be formed in a single step.